Wayne State University, Detroit, Michigan, USA.
Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts, USA.
JACC Heart Fail. 2021 Jan;9(1):42-51. doi: 10.1016/j.jchf.2020.09.012. Epub 2020 Nov 11.
Treatment of heart failure with reduced ejection fraction (EF) may improve patient-reported health outcomes.
The purpose of this study was to determine timing and magnitude of change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 scores following initiation of sacubitril/valsartan and interaction with change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations.
From a single-arm, open-label study of patients initiated on sacubitril/valsartan, KCCQ-23 scores and NT-proBNP were obtained at baseline and follow-up through 12 months. Cross-sectional and longitudinal analyses evaluated magnitude and rate of change in KCCQ-23 scores and associations with NT-proBNP. Patient-level data from the randomized EVALUATE-HF study were used as historic controls.
The analysis cohort (n = 678, age 64.7 years, 71.5% men, EF 28.9%) had a baseline KCCQ-23 overall score (OS) of 65.6. Following sacubitril/valsartan initiation, the majority (n = 412; 60.8%) of participants experienced a rise in KCCQ-23 OS ≥10 points; 26.0% increased by ≥20 points. Comparable improvement in KCCQ-23 scores was seen in various subgroups. Change in KCCQ-23 OS was inversely associated with change in circulating NT-proBNP concentrations. Among a control group of patients in EVALUATE-HF, linear rate of change in KCCQ-12 OS/14-day interval in the enalapril arm was 0.37 points (p = 0.06), whereas in the sacubitril/valsartan arm, scores increased at a rate of 1.19 points (p < 0.001), nearly identical to this dataset (1.08 points; p < 0.001).
Treatment of heart failure with reduced EF with sacubitril/valsartan is associated with rapid and significant improvement in KCCQ-23 scores which was significantly related to change in NT-proBNP. (Effects of Sacubitril/Valsartan Therapy on Biomarkers, Myocardial Remodeling and Outcomes [PROVE-HF]; NCT02887183).
射血分数降低的心力衰竭（HFREF）的治疗可能会改善患者报告的健康结局。
本研究的目的是确定起始沙库巴曲缬沙坦后，堪萨斯城心肌病问卷（KCCQ-23）评分的变化时间和幅度，并与氨基末端脑钠肽前体（NT-proBNP）浓度的变化进行相互作用。
来自一项沙库巴曲缬沙坦单臂、开放标签的研究，患者基线和随访通过 12 个月获得 KCCQ-23 评分和 NT-proBNP。横断面和纵向分析评估了 KCCQ-23 评分的变化幅度和变化率，并与 NT-proBNP 相关。使用随机 EVALUATE-HF 研究的患者水平数据作为历史对照。
分析队列（n=678，年龄 64.7 岁，71.5%为男性，EF 28.9%）的基线 KCCQ-23 总评分（OS）为 65.6。起始沙库巴曲缬沙坦后，大多数（n=412；60.8%）患者的 KCCQ-23 OS 升高≥10 分；26.0%的患者升高≥20 分。在各种亚组中都观察到 KCCQ-23 评分的类似改善。KCCQ-23 OS 的变化与循环 NT-proBNP 浓度的变化呈负相关。在 EVALUATE-HF 中的患者对照组中，依那普利组 KCCQ-12 OS/14 天间隔的线性变化率为 0.37 分（p=0.06），而沙库巴曲缬沙坦组的评分增加率为 1.19 分（p<0.001），与本数据集（1.08 分；p<0.001）几乎相同。
射血分数降低的心力衰竭用沙库巴曲缬沙坦治疗与 KCCQ-23 评分的快速和显著改善相关，这与 NT-proBNP 的变化显著相关。（沙库巴曲缬沙坦治疗对生物标志物、心肌重构和结局的影响[PROVE-HF]；NCT02887183）。
